Incision, excision, vaporization, ablation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

fibroma removal
frenectomy
frenotomy
gingival troughing for crown impressions
gingivectomy
gingivoplasty
hemostasis and coagulation
implant recovery
incision and drainage of abscess
operculectomy
pulpotomy
soft tissue crown lengthening
treatment of herpetic and aphthous ulcers of the oral mucosa.
1. Laser periodontal procedures
laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility.)
1. Whitening
light activation for bleaching materials for teeth whitening
laser-assisted whitening/bleach of teeth
1. Pain Relief
topical heating for the purpose of elevating tissue temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle

Device Description

The SOLASE dental diode laser is a surgical and therapeutic device produced by Lazon Medical Laser Co., Ltd., designed for dental soft tissue indications, laser periodontal procedures, as well as teeth whitening and pain relief. It cannot be used for oral hard tissue.

The SOLASE laser uses a laser diode as the beam source to radiate invisible infrared light, which is delivered to the operating area by optical fiber. It can generate a short laser pulse up to 10us of interval. The SOLASE laser provides two different models with two different wavelengths - 808nm and 976mm, to meet customers' various requirements.

The SOLASE laser is a Class 4 laser product which may cause injuries in improper handling. Therefore, it MUST be operated only by trained and qualified personnel.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

The document (K180967) is a 510(k) Summary for a Dental Diode Laser System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials. As such, the information you've requested about specific acceptance criteria and detailed study designs in the context of AI/algorithm performance is largely not present in this document because it is not an AI-powered device, nor is it subject to specific performance criteria typical of diagnostic or AI-driven tools.

The "acceptance criteria" here primarily refer to meeting recognized safety and performance standards relevant to a medical laser system and demonstrating functional equivalence to a predicate device.

Here's a breakdown based on your questions, with explanations for what is and isn't available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The term "acceptance criteria" is used more broadly in this context to refer to compliance with recognized standards and demonstration of similar technical specifications to predicate devices. There isn't a table presenting specific numerical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) and reported performance against those. Instead, the document focuses on compliance with established international standards for medical electrical equipment and laser safety.

Acceptance Criteria (from Standards Compliance)	Reported Device Performance (from "Substantially Equivalent Comparison" Table)
Electrical Safety: Comply with IEC 60601-1	Comply with IEC 60601-1
EMC: Comply with IEC 60601-1-2	Comply with IEC 60601-1-2
Laser Safety & Surgical Performance: Comply with IEC 60601-2-22 and IEC 60825-1	Comply with IEC 60601-2-22 and IEC 60825-1
Biocompatibility: Non-toxic, non-irritating, non-sensitizing per ISO 10993 series	Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10) - tests were performed, conclusion states "demonstrated as non-toxic, non-irritating, and non-sensitizing"
Performance Data: Difference between set average peak power and measured average peak power meets performance criterion for laser pulse specifications	No specific numerical performance criterion or measured value is given in the summary table, but it states "Performance data showing that the difference... meets performance criterion..." (Page 7)
Indications for Use: To be contained by predicate device's indications	Proposed device's indications are listed and compared to predicate/reference devices (Table 1, Page 8)
Technical Specifications: Similar to predicate devices	Detailed comparison table of specifications like wavelength, max output, power modes, dimensions, etc. (Table 1, Page 8)

2. Sample Size Used for the Test Set and Data Provenance

No specific "test set" in the context of an AI/algorithmic performance study is mentioned. The document is for a medical device (laser system), not an AI diagnostic tool.
The tests conducted were non-clinical (e.g., electrical safety, EMC, laser safety, biocompatibility).
For the biocompatibility tests (ISO 10993-5, -10), the sample size would refer to the number of biological samples or test articles used in the in vitro or in vivo (irritation/sensitization) studies, but this specific detail is not provided in the summary.
Data provenance is not applicable in the sense of patient data in this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This information pertains to studies establishing ground truth for diagnostic AI, which is not the focus of this 510(k) submission for a laser device.

4. Adjudication Method for the Test Set

Not applicable. This relates to human review of AI output or establishing ground truth, which is not part of this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This is a type of clinical study often done for diagnostic devices, especially those with AI components. The document explicitly states: "No clinical study is included in this submission." (Page 7)

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The device is a physical laser system, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by the standards themselves (e.g., acceptable electromagnetic emissions per IEC 60601-1-2, non-cytotoxic result per ISO 10993-5). The device is tested against the requirements of these standards.
For the substantial equivalence claim, the "ground truth" is the technical specifications and indications for use of the predicate devices (Biolase Epic 10 Diode Laser System and Denmat Sapphire ST Portable Laser). The proposed device's characteristics are compared directly to these.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no "training set."

In summary, this 510(k) submission for the Dental Diode Laser System demonstrates substantial equivalence by:

Compliance with recognized non-clinical performance and safety standards: AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, and ISO 10993-10.
Comparison of technical specifications and indications for use to two predicate devices (K121286 and K103667). The reported device performance aligns with or is comparable to the predicate devices and meets the requirements stipulated in the standards.

The document explicitly states that no clinical studies were included, which is typical for a 510(k) clearance where substantial equivalence can be demonstrated through non-clinical testing and comparison to legally marketed devices.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 11, 2018

Lazon Medical Laser Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 Cn

Re: K180967

Trade/Device Name: Dental Diode Laser System, Models: Solace-808 and Solace-976 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: April 3, 2018 Received: April 13, 2018

Dear Diana Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Binita S. Ashar -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180967

Device Name Dental Diode Laser System Models: SOLASE-808 and SOLASE-976

Indications for Use (Describe)

The indications for use of the subject device are given below.

Dental soft tissue indications

Incision, excision, vaporization, ablation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

fiborma removal
frenectomy
frenotomy
gingival troughing for crown impressions
gingivectomy
gingivoplasty
hemostasis and coagulation
implant recovery
incision and drainage of abscess
operculectomy
pulpotomy
soft tissue crown lengthening
treatment of herpetic and aphthous ulcers of the oral mucosa.
1. Laser periodontal procedures
laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility.)
1. Whitening
light activation for bleaching materials for teeth whitening
laser-assisted whitening/bleach of teeth
1. Pain Relief
topical heating for the purpose of elevating tissue temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K180967

1. Date of Preparation: 7/10/2018
1. Sponsor Identification

Lazon Medical Laser Co., Ltd. No.123, Hezuo Street, Dadong District, Shenyang, 110179, Liaoning, China.

Establishment Registration Number: Not yet registered

Contact Person: Gen Cheng Position: General Manager Tel: +86-24-88327588 Email: gen,cheng@lazonlaser.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

Identification of Proposed Device 4.
Device Name: Dental Diode Laser System Model: SOLASE-808 and SOLASE-976 Common Name: Diode Laser

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Regulatory Information

Classification Name: Powered Laser Surgical Instrument Classification: II Product Code: GEX Regulation Number: 21 CFR 878.4810 Review Panel: General and Plastic Surgery

Indications for Use:

The indications for use of the subject device are given below.

1. Dental soft tissue indications
  Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
fiborma removal
frenectomy
frenotomy
gingival troughing for crown impressions
gingivectomy
gingivoplasty
hemostasis and coagulation
implant recovery
incision and drainage of abscess
operculectomy
pulpotomy
soft tissue crown lengthening
treatment of herpetic and aphthous ulcers of the oral mucosa.

2. Laser periodontal procedures

laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility.)

3. Whitening

light activation for bleaching materials for teeth whitening
laser-assisted whitening/bleach of teeth
1. Pain Relief
topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle

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and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

Device Description

The SOLASE laser is a Class 4 laser product which may cause injuries in improper handling. Therefore, it MUST be operated only by trained and qualified personnel.

ડ. Identification of Predicate Device and Reference Device
Predicate Device 510(k) Number: K121286 Product Name: Epic 10 Diode Laser System Model: Epic 10 Manufacturer: Biolase Technology, Inc.

Reference Device 510(k) Number: K103667 Product Name: Sapphire ST Portable Laser Manufacturer: Denmat Holdings LLC.

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6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

A AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
A IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
A IEC 60601-2-22:2012, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment.
IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements.
ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin A sensitization
A Performance data showing that the difference between the set average peak power and the measured average peak power meets performance criterion for the range of laser pulse specifications.
1. Clinical Test Conclusion

No clinical study is included in this submission.

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8. Substantially Equivalent (SE) Comparison

	Proposed Device	Predicate Device	Reference Device
ITEM		K121286	K103667
Product Code	GEX	GEX	GEX
RegulationNumber	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810
Class	II	II	II
Indications forUse	1. Dental soft tissueindicationsIncision, excision,vaporization, ablationand coagulation of oralsoft tissues includingmarginal and inter-dentalgingival and epitheliallining of free gingivaand the followingspecific indications:- fibroma removal- frenectomy- frenotomy- gingival troughing forcrown impressions- gingivectomy- gingivoplasty- hemostasis andcoagulation- implant recovery- incision and drainageof abscess- operculectomy- pulpotomy-soft tissuecrownlengthening-treatment of herpetic andaphthous ulcers of	1. Dental Soft TissueIndicationsIncision, excision,vaporization, ablation andcoagulation of oral softtissues including marginaland inter-dental gingival andepithelial lining of freegingiva and the followingspecific indications:* Excisional and incisionalbiopsies* Exposure of uneruptedteeth* Fibroma removal* Frenectomy* Frenotomy* Gingival troughing forcrown impressions* Gingivectomy* Gingivoplasty* Gingival incision andexcision* Hemostasis and coagulation* Implant recovery* Incision and drainage of	The Sapphire ST PortableDiode Laser is intended foruse in dental intraoral softtissue general, oralmaxilla-facial and cosmeticsurgery. It is intended forablating, incising, excising,vaporizing and coagulation ofsoft tissues using a fiber opticdelivery system. Indicationsinclude excision and incisionbiopsies;, hemostaticassistance; treatment ofaphthous ulcers; frenectomy;frenotomy; gingival incisionand excision; gingivectomy;gingivoplasty; incising anddraining abscesses;operculectomy; oralpapillectomy; removal offibromias; Soft tissue crownlengthening; sulculardebridement (removal ofdiseased or inflamed softtissue in the periodontalpocket); tissue retraction

the oral mucosa.	abscess	for impression;
	* Leukoplakia	vestibuloplasty, and light
	* Operculectomy	activation of bleaching
	* Oral papillectomnies	materials for teeth whitening,
	* Pulpotomy	laser-assisted bleaching
	* Pulpotomy as an adjunct to	/whitening of teeth.
	root canal therapy
	* Reduction of gingival
	hypertrophy
	* Soft tissue crown
	lengthening
	* Treatment of canker sores,
	herpetic and aphthous ulcers
	of the oral mucosa.
	* Vestibuloplasty
	* Tissue retraction for
	impression
2. Laser periodontalprocedures	2. Laser PeriodontalProcedures
- laser removal ofdiseased, infected,inflamed and necrosedsoft tissue within theperiodontal pocket- sulcular debridement(removal of diseased,infected, inflamed andnecrosed soft tissue inthe periodontal pocket toimprove clinical indicesincluding gingival index,gingival bleeding index,probe depth, attachmentloss and tooth mobility.)	* Laser soft tissue curettage* Laser removal of diseased,infected, inflamed andnecrosed soft tissue withinthe periodontal pocket* Sulcular debridement(removal of diseased,infected, inflamed andnecrosed soft tissue in theperiodontal pocket toimprove clinical indicesincluding gingival index,gingival bleeding index,probe depth, attachment lossand tooth mobility.)
	3. WhiteningLight activation for-bleaching materials forteeth whitening*Laser-assistedwhitening/bleachingofteeth4. Pain Relief- Topical heating for thepurpose of elevatingtissue temperature for atemporaryreliefofminor muscle and jointpain and stiffness, minorarthritis pain, or musclespasm, minor sprainsand strains, and minormuscular back pain; thetemporary increase inlocal blood circulation;the temporary relaxationof muscle.	3. Whitening* Light activation forbleaching materials for teethwhitening* Laser-assistedwhitening/bleaching of teeth4. Pain Relief* Topical heating for thepurpose of elevating tissuetemperature for a temporaryrelief of minor muscle andjoint pain and stiffness, minorarthritis pain, or musclespasm, minor sprains andstrains, and minor muscularback pain; the temporaryincrease in local bloodcirculation; the temporaryrelaxation of muscle.
Model	SOLASE-808 andSOLASE-976	Epic 10	/
LaserClassification	N(4)	N(4)	N(4)
Dimensions	13.8cm×14.2cm×16.8cm	14.5cm×11.2cm×16.5cm	Unknown
Weight	1.3kg	1.1kg	1.2kg
Power Supply	100-240VAC	100-230VAC	100-240 VAC
CurrentFrequency	50-60Hz	50-60Hz	50-60Hz
Laser Medium	AlGaAs	InGaAsP	Unknown
Wavelength	SOLASE-808: 808nmSOLASE-976: 976nm	940±10nm	808±5nm
Max Output	CW mode:	10W	CW: 3W

	7W@SOLASE-808,10W@SOLASE-976Pulse mode:12W@SOLASE-808,16W@SOLASE-976		Pulse mode: 5W
Max Peak PulsePower	SOLASE-808: 12WSOLASE-976: 16W	10W	5W
Max AveragePulse Power	SOLASE-808: 6.3W(When peak power is0.1~~7W) and 6W (Whenpeak power is7.1~~12W);SOLASE-976: 9W(When peak power is0.1~~10W) and 8W(When peak power is10.1~~16W)	Unknown	2.5W
Max PowerDensity	SOLASE-808:222.8W/mm²SOLASE-976:318.3W/mm²	318.3W/mm²	23.9 W/mm²
Power Modes	Continuous and Pulse	Continuous and Pulse	Continuous and Pulse
Pulse Length	2.7m	Unknown	Unknown
Pulse Duration	0.01ms-0.9s	0.01ms-20ms	0.1s
Pulse Interval	0.01ms-0.9s	0.01ms-20ms	0.1s
Aiming Beam	2mW, 650nm	1mW, 635±10nm	2mW, 640nm
Fiber Diameter	200µm, 300µm and400µm	200µm, 300µm and 400µm	400µm
Electrical Safety	Comply with IEC60601-1	Comply with IEC 60601-1	Comply with IEC 60601-1
EMC	Comply with IEC60601-1-2	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2
Particularrequirements	Comply with IEC60601-2-22 and IEC60825-1	Comply with IEC60601-2-22 and IEC 60825-1	Comply with IEC60601-2-22 and IEC 60825-1
Patient-contactmaterial	Stainless steel,aluminum, quartz and PP(Polypropylene)	Medical grade plastics, steel,stainless steel, aluminum,brass, and electronic partsand components	Unknown
Biocompatibility	Cytotoxicity, ISO10993-5	Unknown	Unknown
	Sensitization, ISO10993-10
	Irritation, ISO 10993-10

Table 1 Substantially Equivalent Comparison

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The indications of proposed device is contained by those of predicate device, and proposed device and predicate device are similar in specifications. Although some of specifications of predicate device are not known and the materials are different, both the proposed device and predicate device comply the same standards in electrical safety, EMC and particular requirements, and the proposed device is demonstrated as non-toxic, non-irritating, and non-sensitizing per ISO 10993 series standards. The differences between the proposed device and predicate device do not impact the safety and effectiveness.

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Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.